Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device with a risk of harm (foreign substance dislodgement) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 133,793 units of the Sarns High-Flow Aortic Arch Cannula (5.2 mm, 16 Fr). The device is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall covers specific catalog and lot codes distributed nationwide in the United States and in various international markets.
During the production of one lot, Terumo CVS identified a foreign substance on the outer surface of some cannulae connectors. A preliminary investigation determined that the substance was likely deposited during the molding process and can be dislodged from the cannula surface. The exact composition of the particles has not been fully determined in the provided text.
Healthcare facilities and distributors should stop using the affected devices and contact Terumo CVS for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 133,793
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog number: 12315 and Lot codes: 0552019
- 0557299
- 0562142
- 0572238
- 0575869
- 0579315
- 0584831
- 0590890
- 0594622
- 0598430
- 0604045
- 0612256
- 0625339
- 0640189
- 0646473
- 0652905
- 0656574
- 0666574
- 0671713
- and 593606C.
Distribution
Part of a larger recall action
This product is one of 11 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
Similar recalls
- ModerateTerumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
FDA (Devices) · 2014-07-30
- ModerateTerumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate
FDA (Devices) · 2014-07-30
- HighTerumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance
FDA (Devices) · 2012-07-04
- HighTerumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
FDA (Devices) · 2014-07-30
- HighTerumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance
FDA (Devices) · 2012-07-04
- ModerateTerumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate
FDA (Devices) · 2014-07-30